Results published for first one-year, head-to-head study comparing Reminyl and Aricept for Alzheimer's

Results published for first one-year, head-to-head study
comparing Reminyl and Aricept for Alzheimer's

TITUSVILLE, N.J., Aug. 19, 2003 -- Results from the first
one-year, head-to-head study comparing Reminyl (galantamine
hydrobromide) and Aricept* (donepezil hydrochloride) -- two
treatments for mild to moderate Alzheimer's disease -- are
published in this month's issue of the peer-reviewed journal, Drugs
and Aging.

The study found that both drugs maintained activities of daily
living to an equal degree through month nine and had a comparable
effect on abnormal behaviors. However, an advantage for Reminyl was
suggested on two secondary measures of "caregiver burden" in mild
to moderate Alzheimer's disease, and on two assessments of
cognition (the ability to think clearly, reason and learn new
information).

"This year-long study demonstrates once again that medication is
effective in slowing the progression of symptoms in Alzheimer's
disease," said study co- author Roger Bullock, Department of Old
Age Psychiatry, Kingshill Research Centre, Victoria Hospital,
Swindon, UK, adding that it is a "tragedy" that an estimated 70
percent or more of people diagnosed with the illness are not being
treated with medications approved to treat the disorder.

"However, while we found that there were similarities between
these two treatments, there also were differences in cognition and
caregiver burden among patients with moderate Alzheimer's disease,
which prescribers may want to take into consideration."

The rater-blinded, randomized study followed 182 patients who
took 24 mg of Reminyl or 10 mg of Aricept daily. Participants met
criteria classifying them as having moderate to advanced
Alzheimer's disease. At a duration of 12 months, this is the
longest study of its kind.

The study found that Reminyl provided benefit comparable to
Aricept in maintaining basic activities of daily living (such as
bathing and grooming), as measured by the Bristol Activities of
Daily Living (BrADL) scale (the primary efficacy assessment used in
this research). Patients' functional ability remained relatively
constant for both treatment groups for nine months, after which a
small decline was observed.

Likewise, both medications affected abnormal behaviors (such as
paranoia and agitation) to a similar degree (specifically, no
significant difference from scores at the beginning of the study),
as measured by the Neuropsychiatric Inventory (NPI).

When comparing participants' cognitive performance, the study
found some differences between the two drugs. The Mini-Mental State
Examination (MMSE) found that as a group, patients taking Reminyl
maintained levels of cognitive performance that were similar to
those shown at the start of the study. In contrast, the Aricept
group deteriorated significantly. This between-group difference did
not reach statistical significance at the end of the study for the
overall participating group.

However, an analysis of patients who responded to one of the
treatments (as shown by a lack of deterioration in their MMSE
scores) found that "galantamine treatment provided significantly
more sustained cognitive benefits than donepezil treatment." At 12
months, more than half (55.2%) of those receiving Reminyl had
maintained or improved their cognitive performance, compared with
only one-third (32.5%) of patients taking Aricept. A similar
advantage for Reminyl was also observed for patients with moderate
stage disease, with 57.9% of Reminyl patients maintained or
improved cognitive performance vs. 29.9% of Aricept patients. This
group of patients, with MMSE scores of 12 to 18, accounted for
about 85 percent of study participants.

Cognitive performance also was measured using the Alzheimer's
Disease Assessment Scale (ADAS-cog/11). While results for the total
study population were similar for both drugs, the patients with
moderate disease showed a significant benefit for Reminyl compared
to Aricept at 52 weeks. Among these patients, 48.1% of those taking
Reminyl maintained or improved ADAS-cog/11 scores vs. 30.0% of
those taking Aricept.

Finally, the study also assessed caregiver burden (the frequency
and severity of distressing experiences reported by family members
or other non- professionals caring for the patient), using the
Screen for Caregiver Burden (SCGB). After 52 weeks of treatment,
more than two-thirds of the caregivers of patients taking Reminyl
reported the same or reduced caregiver burden, (67% and 68% for
frequency and severity, respectively). This compared to about half
(51% and 49%) of those caring for patients taking Aricept.

Both therapies were generally safe and well tolerated. When used
according to the recommended dosing schedule, the most frequent
side effects of Reminyl include nausea, vomiting, diarrhea,
anorexia and weight loss. These side effects tend to occur when
starting or increasing the doses of the medication, and are usually
mild and temporary. For more information, refer to the full
prescribing information for Reminyl or visit www.reminyl.com. Janssen
Pharmaceutica Products, LP, which markets Reminyl, also supports a
Web site dedicated to caregivers, www.SharingCare.com.

Reminyl is thought to inhibit an enzyme that breaks down
acetylcholine -- a neurotransmitter in the brain that plays a key
role in memory and learning. In addition, it is believed that
Reminyl modulates the brain's nicotinic receptors, to which
acetylcholine binds. The clinical significance of these mechanisms
is unknown.

The medication was developed by J&JPRD under a
co-development and licensing agreement with UK-based Shire
Pharmaceuticals Group plc. Reminyl is marketed by Janssen
Pharmaceutica Products, L.P. and Ortho-McNeil Pharmaceutical in the
United States, Janssen-Ortho in Canada and Janssen-Cilag elsewhere
-- with the exception of the United Kingdom and Ireland, where it
is registered and marketed by Shire under co-promotion agreement
with Janssen- Cilag. The product is approved for the treatment of
mild to moderate Alzheimer's disease in more than 30 countries, and
also is being studied in individuals with vascular dementia and
mild cognitive impairment (believed to be a precursor to
Alzheimer's disease).

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